LeukoSure Enumeration Kit, 200 Tests, CE, IVD
The LeukoSure Enumeration Kit is comprised of a set of reagents used to prepare and enumerate white blood cells in leukoreduced red blood cell and platelet products by flow cytometry. The LeukoSure Enumeration Kit is configured to utilize the sensitivity of flow cytometry to enumerate residual leukocytes at the levels necessary to ensure the quality control of leukoreduced blood.
The enumeration method depends upon mixing a known volume (100 μL) of LeukoSure Fluorospheres with an identical volume of sample to be tested. After analysis the absolute count for the specimen is calculated. This represents the absolute number of leukocytes in the specimen.
The specimen is lysed and permeabilized using the LeukoSure Lyse Reagent to eliminate RBCs and prepare the cells for subsequent addition of the LeukoSure Stain Reagent which contains propidium iodide and RNAse (enzyme used to remove ribonucleic acid, or RNA). In the absence of RNA, propidium iodide binds only to double stranded deoxyribonucleic acid (DNA) so that nucleated cells in the sample emit fluorescence in proportion to their DNA content. The flow cytometer measures the fluorescence from each stained cell as it passes through the laser beam. Since mature platelets and red blood cells do not contain DNA, the stained cells represent the leukocyte component of the blood.
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PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.